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Oxygen Biotherapeutics Selects Duke Clinical Research Institute to Conduct Phase 3 Trial of Levosimendan



  Oxygen Biotherapeutics Selects Duke Clinical Research Institute to Conduct
  Phase 3 Trial of Levosimendan

Phase 3 trials anticipated to begin in Q3 2014 and to be conducted at 50 major
                   cardiac surgery centers in North America

Business Wire

MORRISVILLE, N.C. -- December 11, 2013

Oxygen Biotherapeutics, Inc., (NASDAQ: OXBT), a pharmaceutical company focused
on developing drugs for the acute care market, today announced that it has
selected Duke University’s Duke Clinical Research Institute, (DCRI) to conduct
the Phase 3 trial of the Company’s newly acquired compound, levosimendan. DCRI
is the world’s largest academic clinical research organization, with
substantial experience in conducting cardiac surgery trials. The DCRI will
serve as the coordinating center and Drs. John H. Alexander and Rajendra Mehta
as lead investigators for the Phase 3 trial.

Levosimendan is a calcium sensitizer developed for intravenous use in
hospitalized patients with acutely decompensated heart failure. The treatment
is currently approved in more than 50 countries for this indication. The
United States Food and Drug Administration (FDA) has granted Fast Track status
for levosimendan for the reduction of morbidity and mortality in cardiac
surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS). In
addition, the FDA has agreed to the Phase 3 protocol design under Special
Protocol Assessment (SPA), and provided guidance that a single successful
trial will be sufficient to support approval of levosimendan in this
indication.

Oxygen Biotherapeutics recently acquired the North American rights to develop
and commercialize levosimendan from Phyxius Pharma. It was discovered and
developed by Orion Pharma, Orion Corporation of Espoo Finland.

John Kelley, CEO for Oxygen Biotherapeutics and former co-founder of Phyxius
Pharma commented on this agreement: “We are extremely pleased to have an
organization with the skill and expertise in conducting clinical trials that
DCRI possesses as our partner. They have been responsible for managing a
number of major cardiac surgery trials in the last decade, so their knowledge
of this area of medicine is invaluable to us. At Phyxius Pharma, we worked
with DCRI for the past three years to develop the clinical program for
levosimendan. They played a key role in designing the Phase 3 protocol that
has been approved by the FDA under SPA.”

According to the scientific literature, LCOS occurs in 5-10% of cardiac
surgery patients, and is associated with a 10 – 15 fold increase in mortality.
There is no drug currently approved for the prevention or treatment of LCOS.
The Phase 3 clinical trial will study if levosimendan administered before and
during surgery will reduce the incidence of LCOS and associated morbidity and
mortality. There is substantial scientific evidence for the use of
levosimendan in cardiovascular surgery, with over 25 published articles in
peer reviewed journals and evidence of mortality reduction in some cardiac
surgery trials of more than 50%.

The Phase 3 trial will be conducted in approximately 50 major cardiac surgery
centers in North America. The trial will enroll patients undergoing coronary
artery bypass graphs (CABG) and/or mitral valve surgery who are at risk for
developing LCOS. The trial will be a double blind, randomized, placebo
controlled study seeking to enroll 760 patients. It is expected that
enrollment will begin in the third quarter of 2014, and will take
approximately 18 months to complete. More details on the specifics of the
trial will be released shortly.

John H. Alexander, M.D., MHS, Director of Cardiovascular Research, Duke
Clinical Research Institute said about today’s announcement: “We are excited
to be continuing our work on levosimendan and to move forward with the conduct
of this innovative Phase 3 trial. The prevention of complications after
high-risk cardiac surgery is clearly an area of unmet medical need. Our recent
analysis of the work that has been published on levosimendan to date indicated
a benefit to high-risk cardiac surgery patients at risk for developing LCOS.
This next phase of research will be important to determine whether those
results are verified in a large study. (Harrison et al. J Cardiothorac Vasc
Anesth 2013;27:1224:32)”

About Oxygen Biotherapeutics

Oxygen Biotherapeutics, Inc. is developing medical products for the acute care
market. The company recently acquired the North American rights to develop and
commercialize levosimendan. The United States Food and Drug Administration
(FDA) has granted Fast Track status for levosimendan for the reduction of
morbidity and mortality in cardiac surgery patients at risk for developing Low
Cardiac Output Syndrome (LCOS). In addition, the FDA has agreed to a Phase 3
protocol design under Special Protocol Assessment (SPA), and provided guidance
that a single successful trial will be sufficient to support approval of
levosimendan in this indication. The company also has developed a proprietary
perfluorocarbon (PFC) therapeutic oxygen carrier called Oxycyte® that is
currently in clinical and preclinical studies for intravenous delivery for
indications such as traumatic brain injury, decompression sickness and stroke.

Caution Regarding Forward-Looking Statements

This news release contains certain forward-looking statements by the company
that involve risks and uncertainties and reflect the company’s judgment as of
the date of this release. The forward-looking statements are subject to a
number of risks and uncertainties, including, but not limited to, the
finalization of definitive agreements with DCRI, matters beyond the company's
control that could lead to delays in the clinical study, delays in new product
introductions and customer acceptance of these new products, and other risks
and uncertainties as described in the company’s filings with the Securities
and Exchange Commission, including in its quarterly report on Form 10-Q filed
on September 17, 2013, and annual report on Form 10-K filed on June 26, 2013,
as well as its other filings with the SEC. The company disclaims any intent or
obligation to update these forward-looking statements beyond the date of this
release. Statements in this press release regarding management’s future
expectations, beliefs, goals, plans or prospects constitute forward-looking
statements within the meaning of the Private Securities Litigation Reform Act
of 1995.

Contact:

IRTH Communications
Robert Haag, 1-866-976-4784
oxbt@irthcommunications.com
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